NCT07908927 Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
| NCT ID | NCT07908927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
| Condition | Sinus Pause |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-05-13 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
One of the most serious complications with leadless pacemaker (LP) implants is right ventricle (RV) perforation. Understanding the accuracy of fluoroscopic guidance of implants compared to transthoracic echocardiograms (TTE) and computed tomography angiography (CTA) of the heart will help guide future implant techniques. We hypothesize that TTE-guided implantation would lead to improved safety and accuracy of leadless pacemaker implants. The implanter and two independent electrophysiologists will estimate the location of the implant based on standard fluoroscopic views using RV site nomenclature after the procedure. Each participant will then undergo a TTE and have 3 independent assessments of the implant site. Within 48 hours of the implant, a CTA of the heart will then be performed with contrast, which will serve as the gold standard to determine the actual implant site. The primary endpoint will compare implanting electrophysiologist, fluoroscopy, and TTE predicted location of a new implanted Micra VR or AV2 leadless pacemaker to the implant location found on a gold standard CTA of the heart. The secondary endpoints will compare implant technique (Jugular vs. Femoral) by defining timing of implant procedure, repositioning, and accuracy of predicted implant location. The other secondary endpoints will compare baseline and demographic characteristics (BMI, COPD, LVEF, implant technique) to EKG parameters at final position, fluoroscopy and TTE image quality, acquisition of triangle or Koch and Bachmann area view during TTE.
Eligibility Criteria
Inclusion Criteria: * Male and female patients aged 18-89, inclusive. * All patients undergoing implant of a new Micra VR or AV2 leadless pacemaker. Exclusion Criteria: * Women who are pregnant or breastfeeding * Existing device implant * Breast or Pectoral Implants * Patients with a GFR less than 45, unless the patient is on dialysis (in which case, may be included) * Known allergy to iodinated contrast. * Any other condition or finding that, in the opinion of the investigator, would contraindicate participation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07908927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Sinus Pause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07908927 currently recruiting?
Yes, NCT07908927 is actively recruiting participants. Contact the research team at caitlin.phalunas@ahn.org for enrollment information.
Where is the NCT07908927 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07908927 clinical trial?
NCT07908927 is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The trial plans to enroll 20 participants.